Kornimate/medical-research-clean huggingface dataset:
89zr-trastuzumab pet for imaging the effect of hsp90 inhibition

Conditions: Breast Cancer

Summary: hsp90 inhibition is a potentially new targeted drug modality in the treatment of her2 positive, trastuzumab refractory breast cancer. little is known about the pharmacodynamics of hsp90 inhibitors in vivo, but non-invasive pet/ct imaging in a xenograft mouse model could visualize and quantify her2 reduction after auy922 treatment by 89zr-trastuzumab pet imaging. two doses of 50 mg/kg auy922 resulted in a decrease in her2 expression of approximately 50%, quantified 6 days after the last administration of auy922. visualizing her2 expression in breast cancer patients before and early following hsp90 inhibition by means of 89zr-trastuzumab pet, is likely to provide insight in the early in vivo effect of hsp90 inhibition and could potentially support patient tailored therapy.

this study is designed as a side study to the multicenter, international phase i-ii trial with the hsp90 inhibitor auy922 (protocol cauy922a2101), as part of the biomarker assessment. in protocol cauy922a2101, section 4, the design of this phase i-ii trial is described (p36, 37). briefly, a dose-escalation study is performed according to phase i design. this part is followed by a dose-expansion study according to a phase ii design. in the latter part, breast cancer patients are enrolled that are either refractory to hormone- or trastuzumab treatment (both treatment arms, n=40 patients). patients with her2 positive, trastuzumab refractory breast cancer, will receive a 89zr-trastuzumab pet scan as part of the present side study protocol, which will be performed in collaboration with the royal marsden hospital (united kingdom). to this end, a 89zr-trastuzumab pet scan will be performed before (baseline) and during treatment with the hsp90 inhibitor auy922, as described below. a minimum of six patients are needed to evaluate whether the 89zr-trastuzumab pet scan can be used for the detection of a decrease of her2 expression, induced by hsp90 inhibition.

Eligibility criteria:
inclusion criteria: * patients with her2 positive, trastuzumab (and lapatinib) refractory breast cancer * participation in the phase i-ii trial with hsp90 inhibitor auy922 (in- and exclusion criteria for this study with auy922 are described in protocol cauy922a2101. exclusion criteria: * no participation in the phase i-ii trial with hsp90 inhibitor auy922 (cauy922a2101. clinical trials no. nct00526045a)

Keywords: heat shock protein breast cancer pet imaging trastuzumab
zmax pediatric vs adult concentration for the treatment of acute otitis media

Conditions: Otitis Media

Summary: assess tolerability of different dosing formulations (adult versus pediatric).


Eligibility criteria:
inclusion criteria: * have clinical signs/symptoms of aom in at least 1 ear exclusion criteria: * known or suspected hypersensitivity, or intolerance to azithromycin or other macrolides or to any penicillin, beta-lactam antibiotic or beta lactamase inhibitor * previously diagnosed disease(s) of immune function * treatment with any systemic (intravenous, intramuscular, oral) antibiotic for any indication within 7 days prior to enrollment
safety and pharmacokinetic comparison of co-administration and a combination drug of rosuvastatin and olmesartan in healthy male volunteers

Conditions: Healthy

Summary: this study investigates safety and pharmacokinetic comparison of dwj1276, a combination drug of rosuvastatin and olmesartan (test formulation), and co-administration of rosuvastatin and olmesartan (reference formulation) for single dose in healthy volunteers


Eligibility criteria:
inclusion criteria: * healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease exclusion criteria: * history of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease; * clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ecg tests; * use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication; * use of any substance that could induce or inhibit drug metabolism enzymes

Keywords: pharmacokinetics
surgical staging in cervical cancer prior to chemoradiation

Conditions: Cervical Cancer

Summary: the aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the figo stages iib-iv prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival.

the aim of this study is to determine whether the modified therapy on the basis of operative staging and systematic, pelvine and paraaortal lymphadenectomy for patients with cervical cancer of the figo stages iib-iv prior to introducing radio-chemotherapy leads to a significant improvement of disease-free survival. to this end, 250 patients with histologically verified cancer of the cervix uteri of the stages iib-iv shall be randomised to a standard arm (arm b), whereby the therapy shall be conducted on the basis of the clinical figo stage. the patients randomised to the test arm (arm a), after determining the clinical figo stage, shall initially receive an operative staging in the form of a pelvine paraaortal lymphadenectomy (laparoscopic or open). on the basis of the operatively obtained findings, a ("surgically") modified tumour stage shall be determined. this "surgical" tumour stage, which shall take into account the affection of the lymph nodes, the infiltration of the neighbouring organs and the intraperitoneal spread, shall serve as the basis for the execution of primary, combined radio-chemotherapy. the primary end-point is the disease-free survival of both groups, the secondary endpoints are overall survival, the local control of both groups, as well as the determination of toxicity and the quality of life.

Eligibility criteria:
inclusion criteria: * karnofsky-index =/\> 70, * age between 18 - 70 years * histological assured cervical cancer (by biopsy) * figo stages ii b - iv * written informed consent * patient's ability to cooperate exclusion criteria: * neuroendocrine tumors or histological mixed types containing neuroendocrine fractions * pregnancy, lactation, * distant metastases, except paraaortal metastases * other malignant diseases in anamnesis * pelvic radiotherapy in anamnesis * severe internal diseases * psychiatric diseases which might query the trial attendance or follow-up * hiv-infection or aids * drug addiction * existing motoric or sensoric polyneuropathy \> ctc grad 1

Keywords: surgical staging cervical cancer chemoradiation outcome toxicity
neo-rt: a study investigating whether changing the sequence of treatments (starting radiotherapy followed by hormone therapy before surgery) is feasible

Conditions: Breast Cancer

Summary: four in 10 women diagnosed with breast cancer undergo mastectomy with or without breast reconstruction and less than half are satisfied with how they look unclothed. breast conservation (removing the area with the lump only) can offer less extensive surgery and improved breast appearance, which can therefore increase well-being. intensity-modulated radiotherapy (imrt) closely shapes the radiation beam to the cancer and is currently given after breast surgery. a new combination of imrt followed by hormone treatment given before surgery, may increase the possibility of breast conservation.


Eligibility criteria:
inclusion criteria: * written informed consent to participate * female * aged 18 years and older * ecog performance status 0-2 * histology confirmed invasive breast cancer * er positive (allred score 6-8) * her2 negative * palpable size ≥20mm * grade i-ii (or grade iii if considered not suitable for neo-adjuvant chemotherapy) * considered that radiotherapy will make breast conserving surgery easier * no evidence of non-breast malignancy if treated with curative intent unless the patient has been disease free ≥5 years * unifocal or multifocal disease, i.e. tumour in the same quadrant and breast conserving surgery still feasible exclusion criteria: * contraindications to breast radiotherapy or neo-adjuvant endocrine therapy * bilateral breast cancer * metastatic cancer * multicentric disease * concomitant medical/psychiatric problems preventing completion of study treatment or follow-up * pregnancy * breast feeding
outcome predictors in acute brain injury

Conditions: Acute Brain Injury

Summary: this study will attempt to evaluate clinical, laboratory and radiographic parameters together to assess heir values in outcome prediction from brain injury. patients will be followed up for a period of 6 months, following admission to icu, to assess outcome, using the extended glasgow outcome score (gose). we hypothesise that it is possible to reliably predict outcome in brain injury from the current investigations we have at our disposal.

design- a prospective clinical trial of patients admitted to intensive care with acute brain injury due to trauma. setting- intensive care unit of the alfred hospital clinical examination- day 4 and day 8, icu consultant to assess prognosis and score patient. electrophysiology- day 4 and day 8, ssep and eeg. interpretation by person blinded to the patient. ct brain- day 1, day 4 and day 8. interpretation by radiologist blinded to the patient. blinding- persons blinded to the patients will make all interpretations of investigations. mode of brain injury will be made available. follow up of patients- structured interviews by telephone will be performed at 6 months post injury with the patient alone, relatives/ friend/ carer alone or patient and relatives/ friend/ carer. these will be performed in relation to the extended glasgow outcome scale (gose). statistics- the positive and negative predictive values for the tests will be determined.

Eligibility criteria:
inclusion criteria: * glasgow coma scale \< 9 post resuscitation * intubated and ventilated * traumatic brain injury exclusion criteria: * pregnancy

Keywords: outcome predictors acute brain injury
omega-3 fatty acids in autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: this is a 12-week open label trial to evaluate whether omega-3 fatty acids is effective in reducing the severity of autism and its comorbidities.


Eligibility criteria:
inclusion criteria: * between ages 5 and 18 years old * diagnosed to have autism, asperger syndrome, or pddnos by the dsm-iv criteria; met the autism or spectrum classification for autism diagnostic interview - revised (adi-r) and autism diagnostic observation schedule (ados) * written parental consent for participation * those not on current standard-of-care treatments for asd exclusion criteria: * below 5 and above 18 years old * no formal diagnosis of autism, asperger syndrome or pdd-nos * without written parental consent for participation * those with brain pathology such as serious head injury, epilepsy, etc. * those on current standard-of-care treatment for asd * those with psychotic symptoms, self-injurious behaviours and/or suicidal tendency, and other history of clinically significant medical conditions screened by the attending doctor to have increase the risk associated with study participation * those on other types of medication or supplements or with change in dose
effects of covid-19 in chronic pain

Conditions: Chronic Pain; Covid19

Summary: the aim of this study is to evaluate the effects of the covid-19 pandemic on pain, stress, sleep and quality of life in patients with chronic musculoskeletal pain and the relationships between them. in this cross-sectional study, 100 volunteer patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain were included. age, gender, body-mass index (bmi) and systemic diseases of the participants were recorded as demographic data. data were collected regarding the area of the body where pain is most dominant in the musculoskeletal system and how long the pain has been in these area, whether there is routine use of analgesics before and after the pandemic and the amount if any, whether the person or the person's relatives have a history of covid-19, whether exercising regularly before and after the pandemic. afterwards, the participants were asked to evaluate their general pain severity and global well-being assesment with the visual analog scale (vas) in the pre-pandemic period and in the last month. for pain severity, the patients marked their pain severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and the end point (10) expressing the most severe pain experienced in life; for patient's global assesment the patients marked their global assesment on a line of 10 centimeters (cm) with the starting point (0) expressing very good, and the end point (10) expressing very bad. the distance between the point marked by the patient and the starting point was measured. the higher the measured value meant the greater the severity of the patient's pain and the worse the patient's global assessment \[11\]. subsequently, the patients were asked to answer questions on the perceived stress scale (pss), pittsburgh sleep quality index (psqi) and nottingham health profile (nhp) scales.


Eligibility criteria:
inclusion criteria: * patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain exclusion criteria: * having a history of trauma and surgical intervention in the last 3 months, * having a history of known inflammatory rheumatic disease, * having a history of chronic severe systemic or neurological disease, * having a moderate or severe impairment of cognitive status determined by the minimental test.
optimising fsh dosage during in vitro fertilization fertilization (ivf)

Conditions: Infertility

Summary: during in vitro fertilisation (ivf) treatment, women receive hormone stimulation with gonadotropins to induce growth of several ovarian follicles. selecting the optimal dosage of gonadotropin is important to avoid maturation of too few or too many follicles, which may impair the chances of treatment success, lead to treatment cancellation, or serious side effects. motivated by the lack of standardised procedures to estimate the optimal dosage of gonadotropins, a patient-specific test has been developed to predict the optimal hormone dosage. by measuring internalisation of gonadotropin by the patient's monocytes isolated form the peripheral blood ex vivo, the gonadotropin removal test determines whether a patient needs increased or reduced hormon doses. in this clinical study the investigators compare deviation from optimal outcome at oocyte pick-up day in two patient groups. optimal outcome of stimulation is defined as 10 oocytes collected in the group of patients matching the inclusion criteria of the study. the control group receives starting hormone dosage assigned by the clinician according to standard clinical procedures. the intervention group receives starting hormone dosage adjusted according to the results of the gonadotropin removal test.


Eligibility criteria:
inclusion criteria: * stimulation according to the mid-luteal phase gonadotropin-releasing hormone-agonist protocol * pre-selected starting dose \ 270 iu fsh exclusion criteria: * risk for hyperstimulation * polycystic ovary syndrome * endometriosis stage \>iii * bmi\>33 * anti-mullerian hormone value missing

Keywords: in vitro fertilization
effect of radiofrequency in women with chronic pelvic pain with an associated myofascial syndrome versus myofascial therapy and no treatment

Conditions: Chronic Pelvic Pain

Summary: a randomised clinical trial is being conducted in the gynecology department of the hospital clinic de barcelona in women presenting chronic pelvic pain syndrome due to a myofascial cause which is over a 4 score in the vas scale and not related to an obstetric injury. this study presents 4 groups; two groups receive 8 radiofrequency sessions, one group receives 8 sessions of myofascial release therapy (mrt) and the last group receives no treatment at all (nt). the two rf groups have been divided into a rf intervention group (rfig) and a rf control group (rfcg) which receives sham treatment. the rf groups are double-blinded. other than rf, both groups perform daily thiele massage at home. the sessions last for 20 minutes and take place once a week during 8 weeks. the main variable evaluated is the level of pain during the muscular assessment carried out by an expert pelvic floor physical therapist using the verbal numeric scale in the first session and at the end of the 8 sessions. secondary variables are: sexual function (throughout fsfi questionnaire), pain catastrophizing (ecd), quality of life (eq5d), anxiety and depression (hads), central sensitization (csi) as well as other pelvic floor dysfunction symptoms (pfdi).


Eligibility criteria:
inclusion criteria included women who were: * at least 18 years of age * presenting with pelvic pain persisting for at least 6 months * diagnosed with myofascial syndrome of the pelvic floor muscles (pfm) by a specialist based on physical assessment * presenting with pelvic pain intensity greater than 4 on the visual analog scale (vas) in the last 3 months * agreed to sign the informed consent form. exclusion criteria included the following: * patients who were pregnant * postpartum patients who had given birth within the last year * patients with a history of vulvovaginal pathology * contraindications for the use of radiofrequency: metal implants or active infection * patients with a history of pelvic cancer, including those who had undergone chemotherapy, radiotherapy, and/or brachytherapy.

Keywords: chronic pelvic pain myofascial syndrome radiofrequency manual therapy
post marketing study to evaluate the safety and efficacy of micafungin against fungal infections caused by candida spp or aspergillus spp

Conditions: Aspergillosis; Candidiasis

Summary: the objective of this study is to evaluate the safety and efficacy of intravenous micafungin for the treatment of adult patients in china infected by candida spp or aspergillus spp.


Eligibility criteria:
inclusion criteria: * patients who are diagnosed as proven/probable/possible fungal infection caused by candida or aspergillus based on the chinese guidelines * females of childbearing potential must have a negative pregnancy test within 48 hrs prior to the study and reliable methods of contraception should be started 4 weeks prior to and during the whole study. * patients capable to understand the purposes and risks of the study, who are willing and able to participate in the study and from whom written and dated informed consent to participate in the study is obtained. * failure to fulfill inclusion criteria in another study, is not necessarily an exclusion criteria for this study, assuming other inclusion criteria 1-4 stated above are fulfilled. exclusion criteria: * patient has history of hypersensitivity, or any serious reaction to any component of this product or other echinocandins. * subject is unlikely to comply with the visits scheduled in the protocol in the opinion of investigator or has a history of non-compliance. * pregnant women, nursing mothers, lactating women, and women of child-bearing potential who are unwilling to use reliable contraception for the duration of the study and for 6 weeks following completion of the study. * ast/alt \> 5 times the upper limit of normal (uln) * total bilirubin\> 2.5 times uln * patient has been previously enrolled in this study.

Keywords: micafungin antifungal candidiasis aspergillosis
outcome after needle vs blade achilles tenotomy in clubfoot

Conditions: Club Foot; Achilles Tendon Surgery

Summary: achilles tendon tenotomy is an integral part of the ponseti method, aimed at correcting residual equinus after correction of the adductus deformity. tenotomy rates ranging from 63-95% after full cycle of castings have been reported in literature. percutaneous tenotomy is the gold standard, which can usually be performed in an out-patient setting under local anesthesia using a scalpel blade. a complication rate of 2% (mainly neurovascular injury)has been reported in literature, with accidental sectioning of the peroneal artery being the most common. development of a pseudo-aneurysm after accidental sectioning of the peroneal artery has been reported in a case report; this delayed further clubfoot treatment. percutaneous needle tenotomy has been described by some authors as an alternative technique with very favorable results in a population before walking age. this technique use a large-gauge (16-19 g) needle to percutaneously cut the achilles tendon. although bleeding has been reported following this technique with similar rates as for the percutaneous blade technique, no major complications have been reported as yet using the needle technique. we would like to compare the clinical outcomes and complication rates of both techniques, supporting our hypothesis that both techniques are equally safe and have the same success rate.


Eligibility criteria:
inclusion criteria: * idiopathic clubfoot. * age less than or equal to 36 months at the time of tenotomy. * enrolled at the pehla qadam clinic at the indus hospital in karachi. * fully corrected adductus deformity with residual equinus after a full casting cycle. * completing routine follow up for 3 months post tenotomy. exclusion criteria: * refusal of parents to enroll child into this study. * syndromic clubfoot. * previous treatment for clubfoot (surgical or non-surgical) received. * underlying medical conditions unrelated to clubfoot that may serve as a contra-indication, this decision will be left on the discretion of the treating orthopedic surgeon
autophagy markers in endometrial polyps

Conditions: Endometrial Polyp; Autophagy

Summary: the aim of this research is to evaluate autophagy markers in patients with endometrial polyps

endometrial polyp are benign formations that are frequently encountered in gynecology practice and have malignant potential. it may be asymptomatic in the clinic or may present with abnormal uterine bleeding. although its pathophysiology has not been clearly revealed, there are many studies in the literature about it. however, the autophagy pathway emerges as a subject that has never been evaluated. in this study, the investigators would like to prospectively evaluate beclin 1, lc3a / b and p62 markers in the autophagy pathway in endometrial polyp tissue samples by immunohistochemistry and reveal their importance.

Eligibility criteria:
inclusion criteria: * patients over 35 years of age with a histopathologically confirmed diagnosis of endometrial polyp * patients over the age of 35 whose histopathologically reported normal endometrial biopsy results. exclusion criteria: * are under the age of 35, * those with cognitive dysfunction, * diagnosed with any type of cancer * who are under treatment for cancer, * diabetes mellitus, * hypertension, * endometriosis, * adenomyosis, * chronic endometritis, * have an acute or chronic illness, * patients who have smoked and used alcohol in the last 10 years

Keywords: polyp endometrium beclin 1 lc3 p62